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Clinical Trials/NL-OMON22556
NL-OMON22556
Recruiting
Not Applicable

Cerebellar stimulation to treat refractory epilepsy in children

Erasmus MC0 sites9 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Refractory epilepsy
Sponsor
Erasmus MC
Enrollment
9
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Erasmus MC

Eligibility Criteria

Inclusion Criteria

  • Refractory epilepsy for at least one year, with a seizure frequency of at least four per month.
  • Failure of at least three adequately tried AED regimens, as determined by the principal investigator, including ketogenic diet if appropriate.
  • Age 4 – 18 years at time of inclusion. The first 3 patients are at least 7 years old.
  • Definite diagnosis of epilepsy syndrome as reported by treating clinician according to international standards and confirmed by recruitment team.
  • Written informed consent of parents/caretakers.

Exclusion Criteria

  • Other progressive neurologic or medical diseases.
  • Evident co\-existing non\-epileptic seizures.
  • Candidate for resective epilepsy surgery.
  • Inability to complete neuropsychological tests or complete seizure diaries by caretakers.
  • Vagal nerve stimulators in situ.
  • Surgical contraindications such as coagulation disorders.
  • Contraindications for MRI.
  • Anatomical abnormalities of skull and posterior fossa, precluding safe lead placement and fixation.
  • Immune deficiency.
  • Insufficient space or subcutaneous fat to safely implant stimulator.

Outcomes

Primary Outcomes

Not specified

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